U.S. patent number 9,808,592 [Application Number 13/939,411] was granted by the patent office on 2017-11-07 for nebulizing catheter for bronchial therapy.
This patent grant is currently assigned to Muffin Incorporated. The grantee listed for this patent is Cook Medical Technologies LLC. Invention is credited to Frank J. Fischer, Jr., Jeffry S. Melsheimer.
United States Patent |
9,808,592 |
Melsheimer , et al. |
November 7, 2017 |
Nebulizing catheter for bronchial therapy
Abstract
A nebulizing catheter for bronchial therapy includes a catheter
having a sheath defining an interior space and an open tip. A
nebulizer is positioned in the interior space and located adjacent
the open tip. The nebulizer includes a piezoelectric device. A
liquid mixture is provided and placed in flow communication with
the piezoelectric device for nebulizing a portion of that liquid
mixture into small droplets for use in the bronchial therapy.
Inventors: |
Melsheimer; Jeffry S.
(Springville, IN), Fischer, Jr.; Frank J. (Bloomington,
IN) |
Applicant: |
Name |
City |
State |
Country |
Type |
Cook Medical Technologies LLC |
Bloomington |
IN |
US |
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Assignee: |
Muffin Incorporated (West
Lafayette, IN)
|
Family
ID: |
49914548 |
Appl.
No.: |
13/939,411 |
Filed: |
July 11, 2013 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20140018616 A1 |
Jan 16, 2014 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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61671237 |
Jul 13, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
1/2676 (20130101); A61B 1/05 (20130101); A61M
16/04 (20130101); A61M 16/0463 (20130101); A61M
16/0488 (20130101); A61M 16/0057 (20130101); A61B
1/00091 (20130101); A61M 16/208 (20130101); A61M
11/005 (20130101); A61B 1/018 (20130101); A61B
1/005 (20130101); A61M 2205/502 (20130101); A61M
2205/8206 (20130101) |
Current International
Class: |
A61M
16/04 (20060101); A61B 1/05 (20060101); A61M
11/00 (20060101); A61M 16/00 (20060101); A61M
16/20 (20060101); A61B 1/018 (20060101); A61B
1/267 (20060101); A61B 1/00 (20060101); A61B
1/005 (20060101) |
Field of
Search: |
;128/200.11,207.14,200.14,200.16 ;604/508,510,526,528,529,530 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Dixon; Annette
Attorney, Agent or Firm: Woodard Emhardt Moriarty McNett
& Henry LLP
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This application claims the benefit of U.S. Provisional Application
Ser. No. 61/671,237 filed Jul. 13, 2012 which is hereby
incorporated by reference.
Claims
The invention claimed is:
1. A nebulizing catheter constructed and arranged to extend through
a flexible tube for bronchial therapy, said nebulizing catheter
comprising: a catheter sheath defining an interior space and an
open tip; a nebulizer positioned in said interior space, adjacent
said open tip, said nebulizer including a piezoelectric device; a
one-way air valve positioned within the interior space of said
catheter sheath; and a reservoir positioned within the interior
space of said catheter sheath between said one-way air valve and
said piezoelectric device, said reservoir being constructed and
arranged to retain a liquid mixture, wherein said liquid mixture is
in flow communication with said piezoelectric device for nebulizing
a portion of said liquid mixture into small droplets for use in
bronchial therapy.
2. The nebulizing catheter of claim 1 wherein said liquid mixture
includes modified cells.
3. The nebulizing catheter of claim 1 wherein said reservoir
includes a mesh material.
4. The nebulizing catheter of claim 1 which further includes a
porous material which is adjacent said piezoelectric device, said
porous material being positioned between said reservoir and said
piezoelectric device.
5. The nebulizing catheter of claim 4 wherein said porous material
is in communication with said reservoir.
6. The nebulizing catheter of claim 1 wherein said piezoelectric
device includes a wave generator.
7. The nebulizing catheter of claim 1 wherein said catheter sheath
has an outside diameter of approximately between 3.6 mm and 4.0
mm.
8. The nebulizing catheter of claim 1 wherein said liquid mixture
is supplied to said nebulizing catheter by means of a syringe.
9. The nebulizing catheter of claim 1 wherein said liquid mixture
is supplied to said nebulizing catheter by means of a tube which is
connected to an external supply.
10. The nebulizing catheter of claim 1 wherein said nebulizer
includes a porous plug positioned upstream from said piezoelectric
device.
11. The nebulizing catheter of claim 10 which further includes a
spring, wherein said reservoir is spring-biased by said spring
against said porous plug.
12. The nebulizing catheter of claim 1 wherein said nebulizer
includes a ceramic sleeve positioned around said piezoelectric
device.
13. The nebulizing catheter of claim 12 wherein said ceramic sleeve
defines apertures for the passage of air and said liquid
mixture.
14. The nebulizing catheter of claim 1 which further includes a
holder which is constructed and arranged to assist in the
positioning of said piezoelectric device.
15. The nebulizing catheter of claim 1 wherein said piezoelectric
device is positioned within a ceramic sleeve and wherein a holder
is press-fit into said ceramic sleeve to help maintain the position
of said piezoelectric device.
16. The nebulizing catheter of claim 1 wherein said piezoelectric
device is an ultrasonic transducer.
17. The nebulizing catheter of claim 1 which further includes a
ceramic sleeve and a porous body surrounding said ceramic
sleeve.
18. The nebulizing catheter of claim 1 which further includes a
ceramic sleeve receiving said piezoelectric device and defining a
flow aperture for said liquid mixture.
19. A bronchial therapy device comprising: a supply of air; a
handle connected to said supply of air; a bronchoscope including a
flexible tube; and a nebulizing catheter cooperating with said
handle and extending through said flexible tube, said nebulizing
catheter comprising: a catheter sheath defining an interior space
and an open tip; a nebulizer positioned in said interior space,
adjacent said open tip, said nebulizer including a piezoelectric
device; a one-way air valve positioned within the interior space of
said catheter sheath; and a reservoir positioned within the
interior space of said catheter sheath between said one-way air
valve and said piezoelectric device, said reservoir being
constructed and arranged to retain a liquid mixture, wherein said
liquid mixture is in flow communication with said piezoelectric
device for nebulizing a portion of said liquid mixture into small
droplets for use in bronchial therapy.
20. The bronchial therapy device of claim 19 wherein said reservoir
includes a mesh material.
21. The bronchial therapy device of claim 19 which further includes
a porous material which is adjacent said piezoelectric device, said
porous material being positioned between said reservoir and said
piezoelectric device.
22. The bronchial therapy device of claim 19 wherein said handle
includes a battery which is connected to said piezoelectric
device.
23. A nebulizing catheter constructed and arranged to extend
through a flexible tube for bronchial therapy, said nebulizing
catheter comprising: a catheter sheath defining an interior space
and an open tip; a nebulizer positioned in said interior space,
adjacent said open tip, said nebulizer including a piezoelectric
device; a reservoir positioned within the interior space of said
catheter sheath; a porous plug positioned within the interior space
of said catheter sheath upstream from said piezoelectric device; a
spring positioned within the interior space of said catheter
sheath, wherein said reservoir is spring-biased by said spring
against said porous plug; and said reservoir being constructed and
arranged to retain a liquid mixture, wherein said liquid mixture is
in flow communication with said piezoelectric device for nebulizing
a portion of said liquid mixture into small droplets for use in
bronchial therapy.
24. A method of providing bronchial therapy treatment to a patient
site, said method comprising the following steps: providing a
handle; providing a bronchoscope; providing a nebulizing catheter
which is operatively connected with said handle via said
bronchoscope, said nebulizing catheter including a sheath defining
an interior space, and a nebulizer with a piezoelectric device;
providing a reservoir which is positioned within said interior
space for retaining a liquid mixture; connecting said handle to a
supply of air; extending a tip of said nebulizing catheter through
a flexible tube of said bronchoscope to reach the patient site;
supplying said nebulizing catheter reservoir with said liquid
mixture; and energizing said piezoelectric device for converting
said liquid mixture into small droplets suitable for treatment.
Description
BACKGROUND
The treatment of respiratory ailments often includes the delivery
of medications by the use of a nebulizer. Typically a nebulizer
works by using an air compressor and a nebulizer cup in order to
turn medication into a vapor mist or fog for the patient to inhale.
A variety of nebulizer constructions are known to exist and the
vapor mist or fog of medication may be inhaled passively (from the
surrounding atmosphere) or inhaled actively by the use of an
inhaler. Each inhalation approach includes certain drawbacks which
offer opportunities for design improvements.
In the case of passive inhaling, the nebulizing process dilutes the
medication as it diffuses from the nebulizer machine into the
surrounding atmosphere. As a result of this dilution, a more
concentrated dose of medicine is required in order to achieve the
desired treatment. This process, as described, may be "acceptable"
for certain medicines and certain treatments, at least from a cost
perspective when the medicine is a relatively low cost item.
However, when the nebulizing procedure is used for cell therapy,
the modified cells are too precious to waste. Even if we discount
the loss of modified cells to the surrounding atmosphere, there are
further losses associated with the act of inhaling, whether active
or passive inhaling. Active inhaling causes some of the nebulized
cells to be absorbed by the mouth and throat tissues before
reaching the site needing or targeted for the therapy.
In addition to the fact that the modified cells are too precious to
waste, the therapy is more effective when the modified cells are
delivered directly to the localized area, including the patient
site which will primarily benefit from the treatment. The typical
delivery process for respiratory treatment, consistent with the
prior art, consists of atomizing the modified cells and then
allowing normal respiration to distribute the cells somewhat
uniformly to the entire lung.
As noted, modified cells are too precious to waste. Further, the
therapy is more effective when the modified cells are directed in a
more focused or targeted manner directly to the area or patient
site which will benefit from the treatment. When the delivery of
nebulized modified cells, via normal respiration, extends to the
entire lung, some other areas or portions of the lung receive the
modified cells which are not part of the area or location targeted
for treatment. Since these "other" areas of the lung are not
intended for treatment and thus would understandably not benefit
from receiving the modified cells, a portion of the modified cells
which are delivered to the lung are "wasted". The disclosed
embodiment addresses this prior art issue by providing a nebulizing
catheter which includes the use of a bronchoscope for catheter
delivery and for positioning the dispensing tip of the catheter at
or near the selected treatment site within a lung of the patient or
subject.
In the context of the present disclosure, other prior art methods
of fog-generation for respiratory treatment create droplets larger
than those formed by nebulizing. The result of having larger
droplets means that uptake by the smallest bronchioles and alveoli
will be inhibited and the intended treatment less effective. In
part, this is why nebulizing is a preferred approach for cell
therapy, using modified cells. However, the prior art forms of
nebulizing and the prior art methods of treatment are improved upon
by the disclosed embodiment and the associated method.
Nebulizing results in the creation of smaller-sized droplets, and
thus the reference to "fog", as these smaller-sized droplets are of
"mist" size and carried by an air flow. These smaller droplets are
able to reach farther into smaller passageways of the lungs before
uptake. Because the nebulized droplets are smaller, they exhibit
better uptake via cell-wall transfer. A result of this is that
small dosages of the modified-cell solution (referred to herein as
a "liquid mixture") can be effective when applied directly to the
treatment area or site.
SUMMARY
A nebulizing catheter for bronchial therapy includes a catheter
having a sheath defining an interior space and an open tip. A
nebulizer is positioned in the interior space and located adjacent
the open tip. The nebulizer includes a piezoelectric device. A
liquid mixture is provided and placed in flow communication with
the piezoelectric device for nebulizing a portion of that liquid
mixture into small droplets for use in the bronchial therapy.
A bronchial therapy device includes a supply of air, a handle
connected to the supply of air and a nebulizing catheter which is
connected to the handle. The nebulizing catheter includes a
catheter having a sheath defining an interior space and an open
tip. A nebulizer is positioned in the interior space and located
adjacent the open tip. The nebulizer includes a piezoelectric
device. A liquid mixture is provided and placed in flow
communication with the piezoelectric device for nebulizing a
portion of that liquid mixture into small droplets for use in the
bronchial therapy.
A method of providing bronchial therapy treatment to a patient site
includes the steps of first providing a handle, providing a
nebulizing catheter which is operatively connected to the handle
and providing the nebulizing catheter with a nebulizer which
includes a piezoelectric device. One of the steps being performed
is to connect the handle to a supply of air. A next step is to
position the tip of the nebulizing catheter at the patient site.
Thereafter, the nebulizing catheter is supplied with a liquid
mixture and this liquid mixture is positioned near the nebulizer.
Once all of the component parts and materials are in place, the
piezoelectric device is energized and converts a portion of the
liquid mixture into small droplets which are suitable for bronchial
therapy treatment.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a diagrammatic, perspective view of a bronchial therapy
device according to the present disclosure.
FIG. 1A is an enlarged view of a portion of the FIG. 1 illustration
showing a nebulizing catheter tip positioned in a lung of a
patient.
FIG. 2 is an enlarged perspective view of the tip portion of a
nebulizing catheter which comprises one portion of the FIG. 1
bronchial therapy device.
FIG. 2A is an enlarged detail of the FIG. 2 illustration showing an
alternative structure for liquid mixture delivery.
FIG. 3 is a front elevational view, in full section, of a liquid
mixture reservoir which comprises one portion of the FIG. 2
nebulizing catheter.
FIG. 4 is a front elevational view, in full section, of a nebulizer
and surrounding structure comprising a portion of the FIG. 2
nebulizing catheter.
DESCRIPTION OF THE SELECTED EMBODIMENTS
For the purpose of promoting an understanding of the principles of
the invention, reference will now be made to the embodiments
illustrated in the drawings and specific language will be used to
describe the same. It will nevertheless be understood that no
limitation of the scope of the invention is thereby intended. Any
alterations and further modifications in the described embodiments,
and any further applications of the principles of the invention as
described herein are contemplated as would normally occur to one
skilled in the art to which the invention relates. One embodiment
of the invention is shown in great detail, although it will be
apparent to those skilled in the relevant art that some features
that are not relevant to the present invention may not be shown for
the sake of clarity.
Referring to FIG. 1, a diagrammatic illustration of a bronchial
therapy device 20 is provided which is consistent with the
disclosed embodiment. Although much of the inventive focus herein
is directed to the nebulizing catheter 22, all of the disclosed
components and subassemblies are important to the totality of the
FIG. 1 bronchial therapy device 20 and to an understanding of
bronchial therapy device 20 and its method of use. With continued
reference to FIG. 1, device 20 further includes a continuous
positive airway pressure (CPAP) unit 24, a handle 26 for and
associated with the nebulizing catheter 22 and a flexible
bronchoscope 28.
A CPAP unit, such as unit 24, is a ventilation device which
generates a gentle stream of air. One of the intended uses for this
gentle stream of air is to direct it into the nose and/or the mouth
of a subject or patient during sleep in order to keep the airway
open. This type of device creates positive pressure ventilation for
subjects who are breathing spontaneously in order to keep the soft
palate from collapsing into the airway and thus increase
oxygenation and reduce the work of breathing. Important to the
disclosed embodiment of FIG. 1 is that current CPAP technology is
able to be used in order to generate an inward flow of air at a
programmable level of pressure, and document this flow of air which
is used as part of the intended bronchial therapy.
CPAP unit 24 which is responsible for the supply of air includes an
air outlet port 30 from which the gentle stream of air flows when
CPAP unit 24 is operated. A flexible, hollow air flow conduit 32
(i.e. hose) is connected at one end 34 to CPAP unit 24. The
opposite end 36 is connected to handle 26. Ideally, the connections
at ends 34 and 36 are tight, secure and leak-free so that the full
volume of air from CPAP unit 24 is directed to and reaches handle
26. The actual connection or fitting between flow conduit 32 and
handle 26 can be a pressure fitting, a threaded fitting,
over-molded or a quick-connect fitting, including a bayonet-type
fitting, to mention a few of the suitable options. Similar
structures may be used for the connection of flow conduit 32 to
CPAP unit 24.
The handle 26 (see FIG. 2) is considered an important and
cooperating part of the device which includes nebulizing catheter
22, since handle 26 includes a battery which is used to provide the
electric energy for a piezoelectric device 76 which is positioned
in the distal end 38 of the nebulizing catheter 22. Handle 26 also
includes an ON/OFF switch 40, a control pad 41 and a status display
window 42. Handle 26 also includes wave generator circuitry which
generates the distinct electrical signal which is preferred for
nebulizing the selected medicant solution. This electrical signal
is sent to the piezoelectric device adjacent the distal tip 62. The
control pad 41 enables the nebulizing catheter 22 to be selectively
actuated. Since portions of the handle 26 have a direct effect on
the components of the nebulizing catheter 22 which are found in
distal end 38, it is logical to treat the handle 26 in combination
with the nebulizing catheter 22 as a "nebulizing device" 44 and
this terminology and convention is being adopted for the present
disclosure. The need to adopt a specific agreed terminology such as
"nebulizing device" 44 is due in part to the physical positioning
of the flexible bronchoscope 28 which is downstream from the handle
26 and which receives a portion of the nebulizing catheter 22.
Accordingly, the two (2) components (handle 26 and nebulizing
catheter 22) which are cooperatively connected together comprise
nebulizing device 44.
Nebulizing catheter 22 extends from its point of connection to or
with handle 26 to its opposite distal end which includes open tip
62. For use in describing what is illustrated in the drawings,
nebulizing catheter 22 includes three (3) sections or portions.
These three (3) portions of catheter 22 include portion 50, portion
51 and portion 60. Portion 50 extends between handle 26 and port 56
of bronchoscope 28. Portion 51 extends through bronchoscope 28 and
its flexible tube 58 until the nebulizing portion 60 is reached.
The nebulizing portion 60 is roughly defined as the distal portion
of catheter 22 which includes many of the nebulizing components,
collectively referred to as nebulizer 70. The entirety of
nebulizing catheter 22 provides a means for the passage of the
electrical wiring from a power source in the handle 26 to the
nebulizer 70 and for the flow of air from CPAP unit 24. Each
portion 50, 51 and 60 has an outside diameter size of approximately
between 3.6 mm and 4.0 mm. This diameter size is important for
receipt of the catheter 22 by bronchoscope 28 and by the selected
channel of flexible tube 58.
Handle 26 includes a flow connection port 46 adjacent the proximal
end 48 and receives catheter portion 50. Port 46 is constructed and
arranged with a suitable fitting or other mechanical structure for
connecting to or with the opposite end 36 of flow conduit 32.
Handle 26 further includes a removable battery cover 52 for the
battery (or batteries) (not illustrated) which are connected in the
interior of handle housing 54. As noted above, each catheter
portion 50, 51 and 60 has an outside diameter of approximately
between 3.6 mm and 4.0 mm. This size is important due to the
channel sizes of the bronchoscope 28 and is important for the
overall passage of the nebulizing catheter 22 as well as the
catheter tip 62 which is to be located at or near the treatment
site within the lung of a patient. The catheter portion 50 is
received by handle 26 and is inserted into a connection port 56 of
the flexible bronchoscope 28. While the approximate 4.0 mm size is
maintained for most of catheter 22, open tip 62 includes a slight
taper and thus a slightly smaller outside diameter.
Connection port 56 is often used for sectioning or instrumentation,
but as a point of entry for a flow conduit or catheter, the passage
of media can be in either direction. In the case of bronchial
therapy device 20, catheter portion 50 is inserted into port 56 and
catheter portion 51 extends from port 56 through one (1) of the
channels of flexible tube 58 of flexible bronchoscope 28. The
distal end of catheter portion 51 is integral with nebulizing
portion 60. The continuous catheter 22 which includes portions 50,
51 and 60 together comprise nebulizing catheter 22. While the
nebulizing catheter 22 is a continuous length of tubing, the
reference to nebulizing portion 60 is based on where the majority
of the nebulizing components are housed, and this portion generally
corresponds with distal end 38.
Flexible bronchoscope 28 has a separate and stand-alone unit as a
construction which is considered as being generally typical or
standard of prior art constructions. However, the incorporation of
this flexible bronchoscope into the disclosed bronchial therapy
device 20 is novel and unobvious. Positioning flexible bronchoscope
28 downstream from handle 26 and providing a means for receiving
catheter portion 51 of nebulizing catheter 22 are novel and
unobvious features. This unique combination and arrangement creates
a novel and unobvious device 20 and a novel and unobvious method of
using device 20.
A part of the flexible style is a visualization system which may
include fiber optics and/or a charge coupled device (CCD) or a
complementary metal oxide semiconductor (CMOS) camera. An image is
transmitted from the tip of the instrument to an eyepiece or video
camera at the opposite end. Cables connected to a lever at the hand
piece enable the tip of the instrument to be oriented and the
practitioner is able to navigate the instrument into individual
lobe or segment bronchi.
The flexible tube 58 of flexible bronchoscope 28 is divided into
three (3) channels. The first channel is a fiber optic channel
which delivers illumination to the distal end or tip of the
flexible tube 58. The second channel includes an optic system which
allows the physician to view inside the lungs. The third channel
allows the through passage of catheter portion 51 which is part of
the nebulizing catheter 22, and allows the passage of the distal
end 38 (i.e. portion 60) of nebulizing catheter 22.
As diagrammatically illustrated in FIGS. 1 and 1A, flexible tube 58
is inserted into the patient's (or subject's) mouth and extends
through the airway and into the lungs. For the disclosed
embodiment, the flexible bronchoscope 28 is used to guide the
distal tip 62 of nebulizing catheter 22 to the treatment site
within the lungs. In this way, when a nebulizing "fog" of the
modified cells is produced, those modified cells are delivered
directly to the treatment site. The modified cells are not wasted
by having the fog dispersed to other portions of the lungs which
are not targeted for therapy. The FIG. 1A illustration shows the
distal tip 62 of nebulizing catheter 22 at its treatment site
position within a lung.
Direct application of the nebulized cells according to the present
disclosure is a more efficient method and treatment because those
cells which are inhaled get absorbed by the mouth and throat
tissues before reaching the site needing the therapy. Nebulizing
creates smaller-sized droplets which can reach further into smaller
passageways before uptake. Nebulized droplets are smaller and
therefore exhibit better uptake via cell-wall transfer. Smaller
dosages of modified-cells can be effective when applied directly to
the treatment area. The nebulizing catheter may indwell after
initial treatment until it is determined whether or not additional
treatments are desired.
Referring now to FIG. 2, additional component parts of the
nebulizing catheter 22 are illustrated. As noted thus far, the
nebulizing device 44 includes the combination of handle 26 and
nebulizing catheter 22. The nebulizing catheter 22 includes
catheter portions 50 and 51 in combination with nebulizing portion
60. Nebulizing portion 60 includes distal end 38 and the open
distal tip 62 and the additional component parts now being
described are assembled into and housed by distal end 38. These
additional component parts include a one-way valve 64, spring 66,
reservoir 68, nebulizer 70 and mounting ring 72. Also included is
the electrical wiring 74 from the handle 26 for electrical energy
connection from the battery (or batteries) assembled into the
handle 26 to the piezoelectric device 76 which can be thought of
for the exemplary embodiment as being an ultrasonic transducer.
Piezoelectric device 76 is a part of the nebulizer 70. Nebulizer 70
is positioned adjacent open tip 62.
Valve 64 is a silicone member having a duck-bill construction with
an open proximal end 78 and a normally-closed distal end 80. The
valve 64 is held by alignment ring 82 which seats against
annular-ring spacer 84. Spring 66 is a coil spring which abuts
against ring 82 at one end 86 and abuts against reservoir 68 at the
opposite end 88. Valve 64 is constructed and arranged so as to
easily open in only one flow direction upon receipt of air flow
from the CPAP unit 24. When the air stops flowing or when the flow
of air reaches a very low level, insufficient to open valve 64, the
distal end of valve 64 which includes the two (2) closing flaps,
remains closed. At this point, any reverse flow upstream away from
the location of the nebulizer 70 is prevented from flowing through
valve 64 or flowing past the location of valve 64 due to its
duck-bill construction, the normally-closed condition of distal end
80 and the additional surrounding components and structures which
cooperate with valve 64 to block any upstream flow.
Reservoir 68 (see FIG. 3) includes a fine mesh 90 which is held
within reservoir wall 68a. The fine mesh 90 is constructed and
arranged for capturing and holding a liquid or liquid mixture for
ultimately nebulizing into a fog for treatment. Included as a part
of this liquid or liquid mixture are the modified cells. The
construction and arrangement of the fine mesh 90 retains the
liquid-cell mixture without running, dripping or other forms of
leakage. The fine mesh 90 may be a type of batting of a polyester
material or of similar synthetic materials. A liquid or liquid
mixture containing the modified cells for the desired therapy is
loaded into reservoir 68 by means of a hypodermic needle syringe,
according to one (1) embodiment.
In the exemplary embodiment, the components are sealed into
nebulizing catheter 22 as illustrated and described. Therefore, one
option for filling the reservoir 68 is to introduce an injection
(i.e., filling) hypodermic needle (not illustrated) through sheath
92 at a predesignated location or area generally adjacent to
reservoir 68. The hypodermic needle is used to dispense the
medicant solution into the reservoir. Selecting a compliant
material for sheath 92, such as an elastomeric polymer, allows the
sheath wall to be self-sealing at least to some degree. Any minor
opening or perforation which might remain would be
inconsequential.
The spring 66 is compressed slightly so as to spring bias the fine
mesh 90 portion of the reservoir 68 up against the porous plug 100.
The abutment stack of component parts extends between two (2)
ledges 97 and 98 which are formed on the interior of the catheter
sheath 92. Alignment ring 82 abuts up against spacer 84 which abuts
up against proximal ledge 97. Mounting ring 72 abuts up against
distal ledge 98 and porous body 102 abuts up against mounting ring
72. This spring-biased construction facilitates a type of capillary
action for the flow of liquid from the reservoir 68 to the porous
plug 100.
With regard to the loading of modified cells (as part of a liquid
mixture) into the reservoir, a second embodiment is
diagrammatically illustrated in FIG. 2A. As is illustrated, a small
tube 101 extends through the interior space of sheath 92 and
connects through the outer wall 68a of the reservoir so as to
establish liquid flow communication with fine mesh 90. The small
tube 101 is used as a liquid lumen and is connected to the handle
26 or at least communicates with the handle 26 such that a liquid
mixture, including modified cells, is able to be introduced into
the liquid lumen 101 at or near the location of the handle 26. By
connecting the lumen 101 to the handle 26, the lumen may be filled,
re-filled and/or pre-filled with the working fluid (i.e. the liquid
mixture containing the modified cells, according to one
embodiment). In other embodiments, the working fluid may have a
different composition and/or a different intended use. In other
embodiments, the lumen 101 may be used in other ways such as
providing the capability to be aspirated/pressurized.
The electrical wiring 74 runs down one (1) side of the reservoir
68. In order to position reservoir 68 generally centrally within
the interior space of catheter sheath 92, a spacer 94 is used on
the opposite side of the reservoir between the reservoir 68 and the
sheath 92 wall. The open tip 62 of distal end 38 of sheath 92 (i.e.
a part of the nebulizing portion 60) is tapered, a shape which
results from heat shaping of the material used for sheath 92. A
thicker sheath section 96 is adjacent mounting ring 72 and provides
ledge 98. The mounting ring 72 is positioned between ledge 98 and
nebulizer 70.
Referring now to FIG. 4, the components, construction and details
of nebulizer 70 are illustrated. Included as a part of nebulizer 70
are porous plug 100, porous body 102 and sleeve 104. Sleeve 104
should be substantially rigid and electrically non-conducting. In
the exemplary embodiment sleeve 104 is made out of a ceramic
material. The piezoelectric device (an ultrasonic transducer) 76 is
positioned in the ceramic sleeve 104. The ultrasonic transducer 76
which corresponds to the piezoelectric device in the exemplary
embodiment is suspended in the interior of the cavity defined by
ceramic sleeve 104. This suspension may be achieved by the wiring
"legs" associated with the ultrasonic transducer. Positioned within
the distal end of ceramic sleeve 104 is a press-fit holder 105
which defines perforated outlets for the nebulized fog, identified
herein as outlet passages 106. Holder 105 may be fabricated out of
a ceramic material similar to that used for sleeve 104. Holder 105
helps to maintain the position and location of ultrasonic
transducer 76.
The electrical wiring 74 which comes from the handle 26 is shown as
being connected to the piezoelectric device 76. The ceramic sleeve
104 defines apertures 108 for the passage and mixing of air and
liquid into the vicinity of the piezoelectric device 76. The liquid
mixture which begins in reservoir 68 and migrates to porous plug
100 and therefore to porous body 102 is in air-flow communication
with piezoelectric device 76. This air and liquid mixture is acted
on by the ultrasonic vibrations or waves which are produced by the
piezoelectric device 76 thereby converting this liquid mixture into
a fog composition of extremely small droplets which includes the
modified cells. The produced fog represents an expanded volume
which seeks an exit path of least resistance and this exit path of
least resistance is provided by outlet passages 106.
The nebulizer 70 is described as including a piezoelectric device
76 which in the exemplary embodiment includes at least an
ultrasonic transducer. The phrase "piezoelectric device" could also
be used to broadly cover a variety of components and component
combinations which cooperate with the ultrasonic transducer in some
capacity, such as the referenced wave generator. The fluid
reservoir either contains the modified-cell solution (i.e. the
liquid mixture) or is able to be supplied with the modified-cell
solution, such as via a lumen 101. Thousands of laser-drilled holes
form micro-perforations (i.e. a mesh) in the transducer. When
energized, the vibrations imparted by the ultrasonic transducer
nebulize the solution which directly "fogs" the tissue of the
selected treatment site as the generated fog exits from the distal
tip 62.
The air flow continues as long as the CPAP unit 24 operates. The
amount or volume of liquid which is present when the procedure
begins is based on what was initially injected into reservoir 68.
By placing the porous plug 100 directly up against the open end 110
of reservoir 68, and actually into the fine mesh 90, the liquid
mixture which typically saturates the fine mesh 90 of the reservoir
migrates from the fine mesh 90 to the porous plug 100, similar to
liquid flow due to capillary action. From the porous plug 100 the
liquid mixture flows into the surrounding porous body 102,
essentially by the same flow principal. The flow of air through the
nebulizing catheter 22 is ultimately directed at the porous body
102. The force of the airflow, even though at an extremely low
pressure, is sufficient to pass through the porous body 102 and
porous plug 100, and through the cavity of sleeve 104 such that the
generated fog is transported via this air flow, out through
passages 106 and distal tip 62, and made available to the adjacent
tissue. The mounting ring 72 closes off the distal end or face 112
of the porous body 102 thereby helping to ensure that the path of
least resistance for the airflow (and the liquid mixture being
carried) is through apertures 108. As the liquid concentration in
the porous body 102 is reduced or lowered, the higher liquid
concentration in the reservoir 68 continually replenishes the
diminishing level in porous body 102 and in porous plug 100 due to
capillary action, until the reservoir is depleted or the therapy is
discontinued. This procedure is able to continue until most all of
the liquid mixture which was injected into the reservoir has been
converted into fog or until the treatment at the selected site has
been concluded. Re-filling the reservoir remains an option even
during treatment. Injecting more of the liquid mixture into the
reservoir allows the therapy process/procedure to continue. The
construction and arrangement of nebulizing catheter 22, noting its
small size and flexible construction, allows it to remain in the
patient (i.e. indwell) after initial treatment until it is
determined whether or not additional treatments are desired.
While the invention has been illustrated and described in detail in
the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiment has been shown
and described and that all changes, equivalents, and modifications
that come within the spirit of the inventions defined by following
claims are desired to be protected. All publications, patents, and
patent applications cited in this specification are herein
incorporated by reference as if each individual publication,
patent, or patent application were specifically and individually
indicated to be incorporated by reference and set forth in its
entirety herein.
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